This article appears in the August 2000 edition of the Catholic Medical Quarterly

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The Legal Aspects of Human Cloning

John Duddington


Within the very near future the expert advisory group, established by the Government under the chairmanship of Dr. Liam Donaldson, the Chief Medical Officer of Health, to consider whether human cloning should be allowed, will publish its report. Indeed, this report is overdue, leading to speculation about what it will recommend. What is vital is that, when it does appear, there is a proper informed debate on this issue, something which certainly has not occurred until now. This article is an attempt to contribute to that debate from the legal perspective and, in so doing, to challenge some commonly held assumptions.


What is Meant by Cloning

The term cloning is an ambiguous one, as it can refer to various processes. As is well known, many plants can clone themselves, and have presumably been doing so since life began. I am concerned with cloning in the sense understood in the Report from the Human Genetics Advisory Commission (HGAC) and the Human Fertilisation and Embryology Authority (HFEA) where it is defined as 'producing a cell or organism with the same nuclear genome as another cell or organism2. This definition assumes that, in this type of cloning, the entire genetic identity of an individual is copied, although this is not strictly true. When, for example, Dolly was formed, she inherited not only the genetic material in the parental nucleus but also the small amount of DNA which exists outside the nucleus of each cell and which in this case came from the donor egg. Accordingly, the definition of cloning used in the above Report was not entirely accurate: it is vital that this should be pointed out. Nevertheless, the definition in the Report does make clear the general type of cloning to which it applies.


Reproductive and Therapeutic Cloning

A distinction is sometimes drawn between these two terms, and it seems likely that discussion of the legal and ethical issues will increasingly focus around them. Reproductive cloning is where the intent is to produce more or less identical foetuses and babies and where the egg is implanted into the mother. Therapeutic cloning, by contrast, could be where stem cell lines are developed with a view to medical application. The nucleus of a cell donated by one person would be transferred to an egg mother cell [an oocyte] and the embryo would be grown to generate stem cells which could be induced to form whichever type of cell or tissue was required for therapeutic purposes, such as brain tissue, muscle or skin. The essential difference is that here the object would not be to produce another human being but to treat an existing human being as a source of spare parts for another.

It is noteworthy that the Report3 mentioned that some of those who responded to the earlier Consultation Document concluded that the distinction between reproductive and therapeutic cloning was arbitrary: therefore, the Report, instead of using the term ‘therapeutic cloning,’ spoke of ‘Therapeutic Use of Cell Nucleus Replacement’ (CNR). The reason given in the Report was because ‘it is clear that the term "cloning" carries an automatic stigma for many because of its association with imagery such as that portrayed in "Brave New world"?’5 In other words, the use of the term "cloning" in this context may lead some to object to it, so let us change the term. It is indeed true that later6 a form of CNR is put forward which would not, according to the Report, include cloning as it would simply involve transferring nuclear material from an egg, before that egg was fashioned, into a donor egg from which the nuclear material had been removed. Be that as it may, one can only view this attempt at re_definition with foreboding, as it is strikingly similar to the notion of the ‘pre_embryo’ as distinct from the embryo, a distinction for which the authors of the Warnock Report7 were responsible by stating that research on in-vitro embryos could be carried out up to fourteen days: this led to the term ‘pre embryo’. Not only this, but the Bishop of Oxford, in the debate in the House of Lords on cloning initiated by Lord Alton8, distinguished between ‘cloning of embryos for reproductive purposes’ and ‘research using nuclear replacement technology’. Yet this latter purpose was said in the Report9 to be only one example of what was termed CNR.


The Present Legal Position.

The precise legal position in the U.K. on cloning is uncertain. The starting point must be the Human Fertilisation and Embryology Act 1990. The Act absolutely prohibits certain activities, such as cloning, although there is doubt about precisely what the Act means by this. Other activities, such as the creation of an embryo ex utero or the storage of embryos or gametes, require a licence from the HFEA. If any activity is not covered by the Act then it is not subject to legal regulation at all, and it may be that this is so in the case of human cloning. The problem is simply that in 1990 human cloning was not something which could be precisely legislated for. It will be argued in this paper that there is an urgent need for such legislation.

S. 1 (l)(a) of the Human Fertilisation and Embryology Act 1990 provides that embryo ‘means a live human embryo where fertilisation is complete. S. 1 (l)(b) also uses the term fertilisation by stating that reference to an embryo includes an egg in the process of fertilisation. The problem here, as pointed out by both Wood and Korek,10 is that what Wood calls ‘the reconstituted cell’ which grew into Dolly was, as explained above, never fertilised. There was no fusion of egg and sperm; it was artificially created.

S.3(3)(d) of the Act contains a prohibition on cloning per se by providing that a licence granted by the HFEA cannot authorise ‘replacing a nucleus taken from the cell of any person, embryo or subsequent development of an embryo’. The difficulty here is that, although those words appear to prohibit nuclear transfer cloning, which is what was used in the case of Dolly, once more what precisely occurred in Dolly’s case is not covered because of the use of the word ‘embryo’. In effect, the 1990 Act uses two terms; ‘fertilisation’ and ‘embryo’ which do not cover what is now understood by cloning. As explained above, the Act allows certain activities under a licence, among which is the storing of gametes.

S.4(2) of the Act provides that ‘a licence cannot authorise storing or using gametes in any circumstances in which regulations prohibit their storage or use’ but, as Korek points out11, this may not cover what happened in Dolly’s case. A gamete is a sperm or egg cell; but only the cell membrane was used to create Dolly, and so it could be argued that this is not a gamete. As Wood12 says, ‘to submit otherwise would be analogous to arguing that an egg devoid of its yolk is still an egg’. Furthermore, Schedule 2, paragraphs 3 and 4 of the Act provide that ‘A licence under this paragraph cannot authorise altering the genetic structure of any cell while it forms part of an embryo....’ This, once more, would be fine were it not for the word ‘embryo’, as explained above; but the Government thinks otherwise, as we shall see.

The final relevant part of the Act is s.8 (a) which provides that the HFEA must ‘keep under review information about embryos and any subsequent development of embryos’. Once again, although these words were inserted to enable the HFEA to deal with developments probably unforeseen when this Act was passed, we are still confronted with the word ‘embryo’.

This question of whether human cloning was covered by the 1990 Act exercised the minds of the House of Commons Sciences and Technology Committee.13 In evidence, Dr. Ian Willmot (the ‘creator’ of Dolly) accepted the point made by the Chairman that ‘it is a crucial thing that the word "embryo" be defined in law in such a way that science is clear as to what it actually means ‘14 and, earlier in the discussion, Prof. Bulfield put the point simply ‘An embryo cannot be in the process of fertilisation because it is only an embryo after fertilisation’15 A memorandum submitted by the Department of Health16 stated that it had been agreed with the HFEA to make a joint approach to Counsel on the definition of ‘embryo’ as used in the Act. It also stated that their current legal advice was that ‘if a court was asked to consider the matter it would be likely to come up with a broad construction which would bring the technique used in the cloning of Dolly within the Act.’ The HGAC/HFEA Report then takes up the story17 by stating that following Counsel’s advice ‘both Ministers and the Authority [i.e. the HFEA] .... are content that the Act does allow the HFEA to regulate nuclear replacement into an unfertilised egg through its licensing system’.

The effect is that, at present, any decision on whether to grant a licence to permit reproductive cloning rests entirely with a statutory body (the HFEA) which, although subject to judicial review18 is not subject to any kind of democratic scrutiny or control19. Moreover, we have arrived at this position by the extremely dubious route of assuming that the courts will define the term ‘embryo’ so that it means something which at present it does not. The Report, to be fair, recognised that many would find this unsatisfactory by stating that20 ‘the Government may .... wish to consider the possibility of introducing primary or secondary legislation explicitly21 banning reproductive cloning .

In its response, the Government has simply stated22 that it will ‘keep under continuing review the adequacy of the existing safeguards and the possible need for additional legislation, with a further detailed analysis in 5 years time if necessary’. Furthermore, the Government set up an expert advisory group under Prof. Donaldson. As we saw earlier23, some confusion was created in the HGAC/HFEA Report by labelling some forms of therapeutic cloning as CNR. The Government’s response24 refers to CNR or therapeutic cloning. This, in itself, is important because at least for the moment the term cloning has not been abandoned in relation to therapeutic cloning, but it is noteworthy that the term ‘cloning techniques’ rather than cloning is used. Once again, we see a subtle change in language. The Government asked the expert advisory group to look at the recommendations in the Report25 that two additional purposes for human embryo research should be added to those which are already in the 1990 Act. These will permit the development of methods of therapy for(i) mitochrondial disease and (ii) for diseased or damaged tissues or organs. These additional purposes would be added by regulations made under s.45 of the 1990 Act and would not therefore require fresh legislation.

What an extraordinary result that would be! At one level, it all looks so reasonable. A statutory power to make regulations is exercised so as to add two extra purposes to the existing ones for which licences may be issued. But the basis of this is extremely dubious. The procedure involved is almost certainly ultra vires the 1990 Act; yet it is assumed that the courts would in turn assume that it was covered by the Act and thus any regulations would be intra vires. Yet all this conceals the fact that, for the first time, the law is permitting the actual creation of what many would consider human beings for what are blandly termed ‘therapeutic’ purposes. The only crumb of comfort is that any regulations would require an affirmative resolution of each House: it is a very small crumb.


Human Tissue Act 1961: Removal of tissue from a dead donor

S.1 of the Human Tissue Act 1961 provides that parts may be removed from a person s body after that person’s death provided that they expressed a request that their body or any specified part of it should be used after their death for therapeutic purposes, medical education or research. Any request must be made in writing except that it can be made orally in a person’s last illness if made in the presence of two or more witnesses. This provision may be relevant if, for example, as suggested by Wood26, grieving parents wish to clone a child recently killed in a car crash, in which case the removal of cells from the child would be needed. The consequence, if human cloning was legalised, could well be increased pressure on persons to sign written consents and, possibly, an attempt to develop a doctrine of implied consent.


Human Organ Transplants Act 1989

This Act established a regulatory system for dealings in human organs by, inter alia, making it a criminal offence to deal in organs for transplantation (5.1), and prohibiting transplants between genetically unrelated persons (5.2) except where the Secretary of State provides by regulations. Organs are defined by S.7(2) as ‘any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body’. It is suggested by Kennedy and Grubb27 that the Act does not apply to human gametes because they are unicellular and not a structured arrangement of tissues. Nor does it apply to human embryos because they are not part of the human body. Moreover, the Act refers to transplants whereas embryos are implanted. Finally, it would seem inconceivable that Parliament would have wished to set up two conflicting sets of rules dealing with gametes and embryos, given that the 1990 Act governs this area. There has been a suggestion otherwise28 but it is submitted that the argument in Kennedy and Grubb is unanswerable. Accordingly, it seems very clear that this Act has no application to human cloning. But should it? The truth is no one has given any thought to these issues.


Other legal issues

If human cloning were permitted, there would clearly be major problems to be solved in many legal fields, not least inheritance of property. For example, suppose that X makes a will leaving all of his property to ‘the children’ and then a child (Y) is cloned from X. Is Y X’s child? Probably yes, but then Y will also be the child of X’s own parents, who may well have made a similar will, and whose estate may by now have been distributed. What if, to return to our original example, X and his wife, Z, enter into mutual wills and agree to leave everything to ‘our children’. But Y is not Z’s child. Nor would it be right for legislation to provide that in such a case Y should be deemed to be Z’s child because this may not be what X would intend. And what about distribution under the intestacy rules? Is Y the brother or sister of children born of X and Z? Presumably not. A further point is the extent to which contracts to clone should be legally enforceable. A possible precedent is the Surrogacy Arrangements Act 1985 which is aimed at commercial surrogacy; but I suggest that all contracts to clone should not only be enforceable but that, as with the Surrogacy Arrangements Act, this should be linked with criminal penalties. One could continue with all manner of speculations; but the point is simply that, if we decide to permit human cloning, we are entering a field with unimaginable complications and implications.


Civil Liability

If reproductive cloning is allowed, then it is possible that an action for negligence could be brought by a child who had been born as a result of having been cloned. This action could be based on:

(a) alleged negligence in the actual process of cloning such as selection of the wrong embryo29.

(b) alleged negligence in either the giving or the failure to give advice, such as advice to parents about the possible risks inherent in a particular process.

(c) alleged negligence in allowing a child to be born with a particular genetic inheritance.

(d) alleged negligence in allowing a child to be born in a case where the primary purpose was to provide tissue for another child. This would, as things stand at the present, be much more far_fetched, but would amount to an action that, for instance, the child had been deprived of its rightful status as a child by being born, not for its own sake, but for the sake of another.

Any discussion on how the law might develop can only be speculation, but those who argue in favour of the legalisation of human cloning will need to set out precisely how they would deal with these situations. In addition, existing legislation would need amending, such as the Congenital Disabilities (Civil Liabilities) Act 1976. This provides that a child who is born alive but is disabled as a result of an occurrence before its birth may have an action in negligence against the person responsible for that occurrence. Would the Act apply where, for example, there was an act of negligence in the course of cloning which led to the cloned child being born disabled? The answer is no. The initial problem is that the Act only deals with situations where a duty of care was owed to a parent of the child and, in the case of cloning, there is the obvious difficulty of deciding precisely who that parent is. The message is clear: human cloning has enormous legal, as well as ethical, implications, which the Government cannot ignore and which make the suggestion referred to above, that the matter could be dealt with by simply passing regulations through Parliament, frankly even more absurd.


International Legal Position

The European Convention on Human Rights and Biomedicine,30 which was promoted by the Council of Europe, provides unequivocally in Article 1 (a) that ‘Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited’. The term ‘genetically identical’ is defined in Article 1(2) as where a human being shares ‘with another the same nuclear gene set’. I suggest that, if legislation is eventually passed dealing with human cloning, then this definition could usefully be adopted, as it deals with the problem that, as already discussed, some genes come from the DNA in the egg cell, by, as it were, using only nuclear genes as the point of reference. The prohibition appears to cover therapeutic as well as reproductive cloning, because it provides in Article 7 that the prohibition on cloning human beings covers ‘all nuclear transfer methods seeking to create identical human beings’. The one problem here is with the use of the word ‘identical’ because it repeats the error in the HGAC/HFEA Report which spoke31 of the ‘same’ genetic material when there will be some material from the egg cell. Once again, the urgent need for clear thinking in this area is demonstrated. As Lord Alton pointed out in the House of Lords debate32, two countries did not sign the Protocol to the Convention. One was Germany, which said that it did not need to do so because its own legislation (Federal Embryo Protection Act 1990) completely prohibits experiments on human embryos. The other was the United Kingdom.

The reason why the U.K. did not sign the Protocol was given by Baroness Hayman, when she replied to the debate.33 She stated that, whilst the Government fully supported the principle enshrined in the Protocol, it could not sign it because to do so would also mean signing the Convention itself which contained provisions relating to research on persons not able to give consent which needed to be examined in the light of forthcoming legislation to be introduced by the Government following the Law Commission’s Working Paper ‘Who Decides?’34 It could also be pointed out that by then the Government’s expert Advisory Group, referred to earlier, will have reported: it may have contradictory views.

We must never forget that much of the pressure to legalise at least therapeutic human cloning comes from commercial organisations. When such a body has devised a procedure, it will, naturally, wish to protect its rights to the profits from it with a patent. The Biotechnology Patents Directive35 expressly prohibits patenting ‘processes for the cloning of human beings’36 Once more the familiar problem of definition rears its head because of the doubt whether an embryo which not yet reached the age of 14 days is included as a human being, a point which was discussed earlier in this article. Although large firms may be reluctant to spend even larger sums of money when there is a doubt about patentability, it seems equally clear that, with large sums at stake, the point raised above will be tested in the courts.

It is also noteworthy that in November 1997 UNESCO brought out the Universal Declaration on the Human Genome and Human Rights which provides, in Clause 11, that ‘practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted’. The weakness is in the reference to only reproductive and not therapeutic cloning.


Legal Position in Other Countries

In the U.S.A. President Clinton, shortly after Dolly was born, gave instructions that no federal funds were to be used for the cloning of human beings.37 He also introduced a bill into Congress known as the Cloning Prohibition Bill, which is still being considered. A useful summary of the legal position in other countries is contained at Annex E of the HGAC/HFEA Report38 where it can be seen that some countries, such as Denmark, Germany and Spain, expressly prohibit cloning whereas others, such as France, implicitly do so. The U.K. could appear as a country which implicitly prohibits cloning but, as argued elsewhere in this paper, this may well not be so.



This article has concentrated on the present legal position which one can quite simply sum up by saying that it does not exist. Laws are not, of course, made in a vacuum; it is useful, in conclusion, to take note of the present Parliamentary state of play. Cloning has not, so far as I am aware, been discussed at all on the floor of the House of Commons and has only been raised in the House of Lords in the debate to which reference has already been made and which was initiated, not by the Government but by Lord Alton. In the debate, the Bishop of Oxford set out the views of the Church of England s Board of Social Responsibility, which he chairs and to which reference has already been made. In summary, the Bishop said that the Board was opposed to reproductive cloning but did not unequivocally oppose the legalisation of therapeutic cloning. The danger is that this will be taken, not only as the view of the Church of England, but as the view of the Christian churches as a whole. This happened in 1990 when Lord Habgood, then Archbishop of York, spoke in the House of Lords in favour of embryo research in certain circumstances, and his words were taken as the authentic Christian view. The Church of Scotland, through its Science, Religion and Technology Project, has been active but so far, the Roman Catholic Church has not produced any detailed examination of the whole topic of cloning. Time for doing this is running dangerously short.


Footnotes and references

  1. The author is most grateful to Lord Alton for his help in the preparation of this article and for supplying a copy of the report of the House of Lords debate on cloning which he initiated. He, also wishes to thank Dr. A.P. Cole, past Master of the Guild of Catholic Doctors, for checking the medical and scientific references.

  2. at p.48. This is hereinafter cited as 'the Report .

  3. at 5.1

  4. 'Cloning Issues in Reproduction, Science and Medicine _ A Consultation Document January 1998

  5. at 5.l

  6. at 5.l

  7. Report of the Committee of Enquiry into Human Fertilisation and Embryology HMSO 1984 (Cm 93 14)

  8. H.L. Deb Vol. 600 No 73 at 326 (hereinafter cited as House of Lords debate on cloning)

  9. See above, note 12

  10. Wood, 'To What Extent Can the Law Control Human Cloning? Journal of the British Academy of Forensic Sciences, Vol.39, No. 1, June 1999 at p.5 . Also Korek, NLJ 2nd March 1 997 at 428 . These are the only two legal studies of the legal position in the U.K. known to me, although there are references in 'Law and Human Genetics, Regulating a Revolution Hart Publishing, 1998, which is an invaluable account of the whole area.

  11. See footnote

  12. op. cit

  13. Fifth Report, 1997, The Cloning of Animals for Adult Cells, Vol. 2

  14. para 159

  15. para 154

  16. printed at p.32 of the Committee s Report

  17. at para3.4

  18. R v HFEA (1997) 2 All ER 687

  19. See ‘The 21 Strangers who we allow to play God’ T Utley Daily Telegraph, 17th November 1999, with a reply by Sara Nathan, a member of the HFEA, Daily Telegraph, 19th November 1999 entitled ‘We don’t play God, we only advise’.

  20. at 9.2

  21. the Report’s italics

  22. Cloning Issues in Reproduction, Science and Medicine, June 1999 Cm 4387 at p.3 para 4

  23. at 5.2 of the Report

  24. see footnote 22. At p.5

  25. at 9.3

  26. op.cit.atp.7

  27. Medical Law, Text and Materials 2nd edition, Butterworths,1994, at p.1089

  28. Price and Mackay, The Trade in Human Organs, (1991) NLJ 1272 at 1273

  29. An interesting investigation of a related area is 'Strict Liability and the Supply of Donated Gametes K. Stem, Medical Law Review, Volume 2 No. 3 Autumn 1994, at pps 261_282.

  30. Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (Strasbourg: ETS 164)

  31. Seefootnote2

  32. House of Lords debate on cloning at 318

  33. op. cit. at 350

  34. This is still expected.

  35. European Parliament and Council Directive on the Legal Protection of Biotechnological Inventions COM 97 446 final.

  36. Article 24

  37. The White House, Office of Communications, Directive on Cloning 4th March 1997 Westlaw 91957 (White House)

  38. at pps 46_47


John Duddington is Director of Studies at Worcester Law School and Editor of Law and Justice, the Christian Law Review

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